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MDMA Raises Concerns About Proposed Changes to IDE Process

WASHINGTON, DC – MDMA recently filed comments on the CY
2014 proposed rules for the Medicare Physician Fee Schedule (PFS) and
Hospital Outpatient Prospective Payment System (OPPS). MDMA
noted that CMS’ revision in policy regarding coverage for items and
services used in investigational device exemption (IDE) clinical studies
are significant, and that the agency not finalize them as proposed.

"We believe that the new criteria for
establishing coverage for IDE will lead to actual access problems for
beneficiaries. Moreover, we also have concerns with the centralized
review process and believe that the intended goal of increased
administrative efficiencies will not be achieved,” wrote Thomas Novelli,
MDMA’s Vice President of Government Affairs. "Given the nature and
realities of IDE clinical trials’ use of non-inferiority designs, the
lack of clarity for attainment of the 13 proposed criteria, and the lack
of administrative guidance and appeals procedures, MDMA does not
support CMS proposed revision to the coverage process for medical
devices in IDE clinical trials.”

In addition, regarding OPPS, MDMA raised several concerns about the use
of data from the comprehensive ambulatory payment classifications
(APCs), as well as payments for new technologies and specific codes and
APCs.